| A Work In Progress
This is a compilation of issues, points, instructions, and pointers that have been raised in past reviews. It is not intended to be an outline or to be comprehensive.
WHY HAVE IRB REVIEW?
"The high research value of human biological materials does not override the rights of individuals to protect themselves from possible adverse consequences of the research use of such materials." (National Bioethics Advisory Commission Draft Report, p 124) http://www.scribd.com/doc/23891605/Nbac-Human-Part-Vol2
"Where identifying information exists, however, there must be an unambiguous system of protections to ensure that risks are minimized and that the sample' source's interests are protected."
History, Fear and Unmet Expectations – Many of these words are imbued with stigma.
Recombinant DNA – Eugenics – Control of powerful technologies – Cloning – Cures – Genetic Therapy.
THE TOP HOT TOPICS
Was consent given? For what? Was it documented? Is a sample form available? Would the donor be surprised to learn about your use of the specimen? Might the donor disagree with your access to or use of the specimen? Is consent waiver possible?
Who knows who the donor was? Where is the code held? Who can break it? How and when? When is the code destroyed irreparably? Is the same anonymous, de-linked, de-identified?
By what right has the sample passed from the donor to the acquirer to the user?
SOURCE OF REGULATORY REQUIREMENTS
You need to give the IRB enough information to know which regulations must be applied.
NIH / CHTN
45 CFR 46Research" is defined as a "a systematic investigation ..designed to develop or contribute to generalizable knowledge".
"Human Subject" is defined as a "living individual about whom an investigator ... conducting research obtains: (1) or (2) identifiable private information. ...".
21 CFR 50 and 56
If samples are to be used to develop a product such as a diagnostic device the study should comply.
If identifiable patient records or samples are involved.
Privacy rules / Consent rules
Many states have rules regarding protection of patient privacy. It is the responsibility of the site to know their specific state requirements.
Internal Rules / IRB policies
Many institutions have institutional and IRB rules about secondary use of diagnostic or pathologic specimens. Any acquirer from an institutional source should be sure that institutional rules have been followed.
PROTOCOL ISSUES TO BE CONSIDERED
Any complete protocol should address the circumstances under which the specimen was obtained, the trail of handling from the acquirer to the user and the purposes for which it will be used. Every protocol will, however, put emphasis on different areas. This is NOT intended to be applied as an outline. It makes a terrible outline.
A. INTRODUCTION There should be an overview describing what is being done and why. It should be in language accessible to all members of the IRB.
When the IRB reads the application, will they receive a coherent picture of what you want and why?
When you have written your application, consider an unbiased assessment from an uninvolved friend.
To do research is a privilege, not a right. It is not a scientists’ absolute right to have access to samples; it is a right limited by ethics, laws, public perception and common sense.
A simple overview should be given. It should include a purpose, rationale, parties involved, and control points in the handling of the sample plus some information on how this study fits into the larger scientific environment.
B. TISSUE ACQUISITION ISSUES An IRB needs assurance that the original acquisition of the tissue was ethical.
1. Why did the initial collection occur?
2. Consent (If the sample is from a repository you may need their assurances. If you are obtaining the sample, the consent form will need review.)
Sample Consent Form statements and Critiques:
Statement: Purpose: "to examine, to retain for science or education or to dispose of."
Critique: None of the three verbs include to give or to sell to an outsider.
Statement: "... will not be used for commercial purposes."
Critique: A commercial company is presumed to have a commercial purpose.
Statement: "... will not be sold ... “
Critique: A transaction that is solely to cover the costs of collection is considered a sale.
Statement: "... will not be used for any genetics research..."
Critique: This would include both basic and applied genetic research.
Statement: "... will be destroyed.”
Critique: This is clear. It cannot be used.
Statement: "... will be used by an outside drug or biotechnology company for their basic research which might, some day, produce a product..."
Critique: This is clear. It is likely it can be used.
3 Ownership and Financial issues
6. Adherence to source institution rules
7. Involvement of middlemen
C. THE SAMPLE ITSELF As various kinds of samples are viewed differently, the IRB must know about the types of samples being sought.
1. Population (similar to “eligibility” criteria and often on your requisition form)
2. Type of specimen (There could be emotional, safety, religious differences)
3. Amount needed
4. Identity Linkages: (CRITICAL)
5. Demographics - Information available
6. Packing and Shipping
D. RESEARCH PROJECTS - END USE The IRB must be assured that the purpose is consistent with the donor's consent, that protections are continued and that use is consistent with "community" and "local" values.
1. Source of sample.
2. Consent – Is this use allowed or precluded by the donor’s stated intent or is the donor intent unknown? (see consent critique above)
3. Origination of request for sample
4. Specificity of study goals:
5. Specificity of study design
6. Data requirements / needs
7. Financial return
What will happen to the sample when the user is finished?
(Triage Categories taken from presentation by Barbara Handelin 8/00)
1. Family Studies
2. Gene Modification studies
3. Population Association Studies (e.g., fishing expeditions)
|Last Updated ( Tuesday, 08 March 2011 21:26 )|